Status:
COMPLETED
Fitmore Hip Stem PMCF Study: A Multi-centre, Non-comparative, Prospective Post-market Clinical Follow-up Study.
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
18+ years
Brief Summary
A multi-centre, non-comparative, prospective post-market clinical follow-up study to obtain survival, clinical and radiographic outcomes data on the Zimmer Fitmore Hip Stem.
Detailed Description
The objective of this post market surveillance study is to obtain outcome data on the Fitmore Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to asses...
Eligibility Criteria
Inclusion
- Patients who are capable of understanding the doctor"s explanations, following his instructions and who are able to participate in the follow-up program.
- Patients who have given written consent to take part in the study by signing the "Patient Consent Form".
- 18 years minimum.
- Male and female.
- Patients suffering from severe hip pain and disability requiring hip surgery or as indicated in the treatment of a fracture.
Exclusion
- Patients who are unwilling or unable to give consent or to comply with the follow-up program.
- Pregnancy.
- Patients who are skeletally immature.
Key Trial Info
Start Date :
February 8 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 10 2023
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT03411044
Start Date
February 8 2008
End Date
June 10 2023
Last Update
November 5 2024
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Auguste Viktoria Klinik
Bad Oeynhausen, Germany, 32545
2
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
3
Clinica San Michele
Albenga, Italy, 17031
4
Kantonsspital Graubünden
Chur, Switzerland, 7000